Roundtable Discussions

Tuesday, July 15 l 16:00 - 17:30

Join your colleagues for these in-depth interactive sessions where a panel of experts will share their findings and opinions, creating an extended discussion on focused topics. This is a great opportunity to connect with colleagues with similar interest. Roundtable Discussions taking place this year include:

Ocular Drug Delivery

Oral Drug Delivery

Ocular Drug Delivery Roundtable

Polymers in Ocular Drug Delivery – More Than Meets the Eye?

Chairs:Ilva Rupenthal, University of Auckland, New ZealandAndrew Urquhart, Technical University of Denmark, Denmark

Topical application of eye drops is still the most common method for treating anterior segment diseases. However, the protective ocular barriers prevent achieving an effective drug concentration at the target site. Many polymers have been investigated over the years to overcome the poor drug bioavailability associated with conventional eye drops and to develop sustained release systems for intravitreal or periocular application. This session will focus on recent advances in polymeric formulations used for ocular drug delivery and will feature invited presentations followed by a panel discussion.

Speakers

Maria José Alonso, University of Santiago de Compostela, Spain

Nanocarriers That Help Overcoming the Ocular Barriers

In the early 90’s we reported for the first time the ability of polyester nanocapsules to overcome the corneal barrier. A number of studies performed with a variety of nanocarriers allowed us to identify critical parameters that affected their interaction and transport across the corneal and conjunctival epithelia. For example, while the PEGylation of the nanocarriers affected their penetration depth into the corneal epithelium, the use of chitosan-based nanocarriers increased their interaction with the corneal epithelium. Some of these nanocarriers, i.e. the chitosan-based ones, were shown to help the transport of peptides, i.e. cyclosporine A, whereas others containing hyaluronic acid resulted in very efficient transport of pDNA across the cornea. Currently, we are performing biocompatibility and biodistribution studies intended to analyze the potential of novel polypeptide and hyaluronic acid nanocarriers for the ocular delivery of nucleic acid-based drugs.

David W. Grainger, University of Utah, U.S.A.

Sustained Release Ocular Delivery: Many Have Tried, Few Have Succeeded

Many patients are unable to self-administer chronic eye drops effectively, including aging populations and pediatric patients. Evidence demonstrates patient inability to effectively self-dose and administer drops accurately and as prescribed even if they want to. A recent study revealed that most glaucoma patients were unable to get a drop into their eye, and only 39% did so without touching the bottle to the surface of the eye. These studies confirm long-known compliance issues, eye drop wastage, potential contamination of the eye drop bottles, and poor understanding of the situation among participants. Alternative ocular delivery modes that reduce administration frequency and sustained release will 1) improve local ocular and systemic safety and tolerability, 2) reduce local drug dosing, and 3) more effectively and efficiently manage ocular disease and resources by better targeting disease and reducing patient visits. Several novel and innovative sustained release (SR) methods target front of the eye (anterior segment and ocular surface) and back of the eye (intraocular retinal) pathologies. Development of viable, reproducible SR technology must consider 1) formulation work (standardizing the release kinetics and duration of action), 2) clinical study design and patient population (determining the timing of replacement or refill and identifying acceptable safety risk profiles versus the comparator), 3) encouraging physician and patient acceptance of perhaps more invasive procedures, and 4) navigation of reimbursement issues to establish the rationale of a perhaps more costly product versus current comparators. This presentation reviews some broad drug delivery platforms, summarizes the current scenario for treating ocular pathology with these SR delivery modes, and identifies data needed for novel technology to be clinically viable marketed products.

Michael O'Rourke, GrayBug LLC, U.S.A.

What's New in Industry - An Update on Ocular Drug Delivery Companies

The global ophthalmic pharmaceutical market is expected to be worth $22 billion total by 2018. Yet only four intraocular slow release systems are approved today, due in part to the challenges of matching new technologies with drug pharmacokinetics. Since 2006, anti-VEGF treatments via intravitreal injection have been launched for retinal diseases, including wet AMD, with great success. However, major drawbacks with this approach remain particularly with the need for frequent injections. The race is on to develop new sustained release drug delivery approaches, not only for AMD but also for glaucoma, diabetic retinopathy and other major diseases including the anterior segment. Controlled release ocular drug delivery offers a major opportunity for new product innovation and sustained competitive advantage. A significant number of new ocular drug delivery companies have therefore emerged to tackle this problem as they aspire to achieve breakthrough multi-billion dollar success. This presentation will provide an overview of some of these companies and their innovative drug delivery strategies.

Oral Drug Delivery

Continuous Processing of Oral Modified Release Products

Chair: Ali Rajabi-Siahboomi, Colorcon, Inc., U.S.A.

It has taken the pharmaceutical industry many years to acknowledge, understand, and accept the principles of quality by design (QbD). Now that the concept is in place in the minds of most formulators and manufacturers, the evolution of QbD is to use continuous processing for manufacturing of pharmaceutical products. This comes with many challenges from the design and technology to the regulatory hurdles. There are efforts among leading scientists and machine manufacturers in this area to evolve the historical mindset of batch manufacture to continuous processing. Key advantages from quality, economy, and speed to market can be gained through this evolution. This roundtable session will provide an overview of current activities with the background of the principles, followed by case studies to show the challenges and opportunities. Please join us to hear from industry leaders on this hot topic and share your experiences and concerns during the discussion.

Speakers

Ali Rajabi-Siahboomi, Colorcon Inc., U.S.A.

Opportunities and Challenges of Continouse Processing

Salvatore Mascia, Continuus Pharmaceuticals, MIT, U.S.A.

Recent Advances in Continuous Manufacturing of Drug Products from Basic Raw Material to Finish Dosage From (end-to-end) on one-line